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Early vs expectant artificial rupture of membranes following Foley catheter ripening: a randomized controlled trial

Published:February 05, 2022DOI:https://doi.org/10.1016/j.ajog.2021.11.1368

      Background

      Early amniotomy shortens the duration of spontaneous labor, yet there is no clear evidence on the optimal timing of amniotomy following cervical ripening. There are limited high-quality studies on the use of early amniotomy intervention following labor induction.

      Objective

      This study aimed to evaluate whether amniotomy within 1 hour of Foley catheter expulsion reduces the duration of labor among individuals undergoing combined misoprostol and Foley catheter labor induction at term.

      Study Design

      This was a randomized clinical trial conducted from November 2020 to May 2021 comparing amniotomy within 1 hour of Foley catheter expulsion (early artificial rupture of membranes) with expectant management. Randomization was stratified by parity. Labor management was standardized among participants. Individuals undergoing induction at ≥37 weeks with a singleton gestation and needing cervical ripening were eligible. Our primary outcome was time to delivery. Wilcoxon rank sum, Pearson chi-square, and Cox survival analyses with intent-to-treat principles were performed adjusting for age, body mass index, parity, mode of delivery, Bishop score, and the interaction between randomization group and parity. A sample size of 160 was planned to detect a 4-hour reduction in delivery time.

      Results

      A total of 160 patients (79 early artificial rupture of membranes, 81 expectant management) were randomized. Early artificial rupture of membranes achieved a faster median time to delivery than expectant management (early artificial rupture of membranes: 11.1 hours; interquartile range, 6.25–17.1 vs expectant management: 19.8 hours; interquartile range, 13.2–26.2; P<.001). A greater percentage of individuals in the early artificial rupture of membranes group delivered within 24 hours (86% vs 70%; P=.03). There was no difference in the cesarean delivery rate between the 2 groups (22% vs 31%; P=.25). Individuals delivered 2.3 times faster following early artificial rupture of membranes (hazard ratio, 2.3; 95% confidence interval, 1.5–3.4; P<.001). There were no significant differences in maternal and neonatal outcomes.

      Conclusion

      Amniotomy within 1 hour of Foley catheter expulsion resulted in 2.3 times faster delivery than expectant management. Therefore, early artificial rupture of membranes should be considered in individuals undergoing mechanical cervical ripening at term.

      Key words

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      References

        • Martin J.A.
        • Hamilton B.E.
        • Osterman M.J.K.
        • Driscoll A.K.
        Births: final data for 2018.
        Natl Vital Stat Rep. 2019; 68: 1-47
        • Levine L.D.
        • Downes K.L.
        • Elovitz M.A.
        • Parry S.
        • Sammel M.D.
        • Srinivas S.K.
        Mechanical and pharmacologic methods of labor induction: a randomized controlled trial.
        Obstet Gynecol. 2016; 128: 1357-1364
        • Gomez H.B.
        • Hoffman M.K.
        • Caplan R.J.
        • Ruhstaller K.
        • Young M.H.H.
        • Sciscione A.C.
        Buccal vs vaginal misoprostol combined with Foley catheter for cervical ripening at term (the BEGIN trial): a randomized controlled trial.
        Am J Obstet Gynecol. 2021; 224: 524.e1-524.e8
        • Grobman W.A.
        • RM
        • Rice M.M.
        • Reddy U.M.
        • et al.
        Labor induction versus expectant management in low-risk nulliparous women.
        N Engl J Med. 2018; 379: 513-523
        • Son M.
        • Roy A.
        • Stetson B.T.
        • et al.
        High-dose compared with standard-dose oxytocin regimens to augment labor in nulliparous women: a randomized controlled trial.
        Obstet Gynecol. 2021; 137: 991-998
        • Wing D.A.
        • Jones M.M.
        • Rahall A.
        • Goodwin T.M.
        • Paul R.H.
        A comparison of misoprostol and prostaglandin E2 gel for preinduction cervical ripening and labor induction.
        Am J Obstet Gynecol. 1995; 172: 1804-1810
        • Luthy D.A.
        • Malmgren J.A.
        • Zingheim R.W.
        Cesarean delivery after elective induction in nulliparous women: the physician effect.
        Am J Obstet Gynecol. 2004; 191: 1511-1515
        • Wei S.
        • Wo B.L.
        • Qi H.P.
        • et al.
        Early amniotomy and early oxytocin for prevention of, or therapy for, delay in first stage spontaneous labour compared with routine care.
        Cochrane Database Syst Rev. 2013; 8: CD006794
        • Fraser W.D.
        • Marcoux S.
        • Moutquin J.M.
        • Christen A.
        Effect of early amniotomy on the risk of dystocia in nulliparous women. The Canadian Early Amniotomy Study Group.
        N Engl J Med. 1993; 328: 1145-1149
        • Battarbee A.N.
        • Palatnik A.
        • Peress D.A.
        • Grobman W.A.
        Association of early amniotomy after Foley balloon catheter ripening and duration of nulliparous labor induction.
        Obstet Gynecol. 2016; 128: 592-597
        • Pasko D.N.
        • Miller K.M.
        • Jauk V.C.
        • Subramaniam A.
        Pregnancy outcomes after early amniotomy among Class III obese gravidas undergoing induction of labor.
        Am J Perinatol. 2019; 36: 449-454
        • Battarbee A.N.
        • Glover A.V.
        • Stamilio D.M.
        Association between early amniotomy in labour induction and severe maternal and neonatal morbidity.
        Aust N Z J Obstet Gynaecol. 2020; 60: 108-114
        • Bostancı E.
        • Eser A.
        • Yayla Abide C.
        • Kılıccı C.
        • Kucukbas M.
        Early amniotomy after dinoprostone insert used for the induction of labor: a randomized clinical trial.
        J Matern Fetal Neonatal Med. 2018; 31: 352-356
        • Ghafarzadeh M.
        • Moeininasab S.
        • Namdari M.
        Effect of early amniotomy on dystocia risk and cesarean delivery in nulliparous women: a randomized clinical trial.
        Arch Gynecol Obstet. 2015; 292: 321-325
        • De Vivo V.
        • Carbone L.
        • Saccone G.
        • et al.
        Early amniotomy after cervical ripening for induction of labor: a systematic review and meta-analysis of randomized controlled trials.
        Am J Obstet Gynecol. 2020; 222: 320-329
      1. Committee Opinion No 700: methods for estimating the due date.
        Obstet Gynecol. 2017; 129: e150-e154
        • Carbone J.F.
        • Tuuli M.G.
        • Fogertey P.J.
        • Roehl K.A.
        • Macones G.A.
        Combination of Foley bulb and vaginal misoprostol compared with vaginal misoprostol alone for cervical ripening and labor induction: a randomized controlled trial.
        Obstet Gynecol. 2013; 121: 247-252
        • Selin L.
        • Wennerholm U.B.
        • Jonsson M.
        • et al.
        High-dose versus low-dose of oxytocin for labour augmentation: a randomised controlled trial.
        Women Birth. 2019; 32: 356-363
        • Harris P.A.
        • Taylor R.
        • Thielke R.
        • Payne J.
        • Gonzalez N.
        • Conde J.G.
        Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support.
        J Biomed Inform. 2009; 42: 377-381
        • Levy R.
        • Ferber A.
        • Ben-Arie A.
        • et al.
        A randomised comparison of early versus late amniotomy following cervical ripening with a Foley catheter.
        BJOG. 2002; 109: 168-172
        • Macones G.A.
        • Cahill A.
        • Stamilio D.M.
        • Odibo A.O.
        The efficacy of early amniotomy in nulliparous labor induction: a randomized controlled trial.
        Am J Obstet Gynecol. 2012; 207: 403.e1-403.e5
        • Herbst A.
        • Källén K.
        Time between membrane rupture and delivery and septicemia in term neonates.
        Obstet Gynecol. 2007; 110: 612-618
        • Seaward P.G.
        • Hannah M.E.
        • Myhr T.L.
        • et al.
        International Multicentre Term prelabor Rupture of Membranes Study: evaluation of predictors of clinical chorioamnionitis and postpartum fever in patients with prelabor rupture of membranes at term.
        Am J Obstet Gynecol. 1997; 177: 1024-1029
        • Barrett J.F.R.
        • Savage J.
        • Phillips K.
        • Lilford R.J.
        Randomized trial of amniotomy in labour versus the intention to leave membranes intact until the second stage.
        Br J Obstet Gynaecol. 1992; 99: 5-9
        • López-Zeno J.A.
        • Peaceman A.M.
        • Adashek J.A.
        • Socol M.L.
        A controlled trial of a program for the active management of labor.
        N Engl J Med. 1992; 326: 450-454
        • Cammu H.
        • Van Eeckhout E.
        A randomised controlled trial of early versus delayed use of amniotomy and oxytocin infusion in nulliparous labour.
        Br J Obstet Gynaecol. 1996; 103: 313-318
        • Cahill A.G.
        • Duffy C.R.
        • Odibo A.O.
        • Roehl K.A.
        • Zhao Q.
        • Macones G.A.
        Number of cervical examinations and risk of intrapartum maternal fever.
        Obstet Gynecol. 2012; 119: 1096-1101